Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelin
- PDF / 543,968 Bytes
- 5 Pages / 595.276 x 790.866 pts Page_size
- 48 Downloads / 165 Views
RESEARCH
Open Access
Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening Ajmal Akbari1, Davy Vanden Broeck1,2,3,4* , Ina Benoy1,2,4, Elizaveta Padalko2,5, Johannes Bogers1,2,3,4 and Marc Arbyn6
Abstract Background: Cervical cancer screening with assays detecting DNA of high-risk human papillomavirus (hrHPV) types is more effective than cytology-based screening. This study completes the diagnostic accuracy assessment conducted previously within the framework of VALGENT-2 (Validation of HPV genotyping Tests) and aims to determine whether the reproducibility of Xpert HPV is in line with international validation criteria. Methods: Validation of new hrHPV DNA assays requires demonstration of good reproducibility and non-inferior clinical accuracy for cervical precancer compared to a standard comparator assay. The international reproducibility criteria are: lower bound of 95% confidence interval of the intra- and inter-laboratory agreement regarding detection of high-risk HPV DNA exceeding 87% with kappa ≥0.5. Results: The Xpert HPV assay showed high intra-laboratory reproducibility with an overall positivity/negativity agreement of 96.9% and a kappa of 0.925. Inter-laboratory testing showed an agreement of 97.8% with a kappa of 0.948. Conclusions: The Xpert HPV assay fulfills the HPV test reproducibility criterion requirement for use in cervical cancer screening. Keywords: Human papillomavirus, Real-time sequencing, Cervical cancer screening
Background High level of evidence from large randomized trials currently exists which indicates that human papillomavirus (HPV) based assays are more effective than cytology screening to reduce the burden of severe cervical dysplasia and cancer [1]. Two HPV assays were used in the randomized trials, Hybrid Capture 2 (HC2) and GP5+/6+ polymerase chain reaction-enzyme immunoassay (PCR-EIA). International guidelines have been widely adopted for the clinical validation of novel HPV tests. In a population of screened women of at least 30 years of age, the * Correspondence: [email protected] 1 AMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Antwerp, Belgium 2 National Reference Centre for HPV, Brussels, Belgium Full list of author information is available at the end of the article
novel HPV test should demonstrate non-inferior sensitivity and specificity for cervical intraepithelial neoplasia grade 2+ (CIN2+) compared to the standard comparator tests (Hybrid Capture 2 (HC2) HPV DNA test or GP5 +/6+ PCR EIA) [2]. In addition, the novel HPV test should demonstrate high intra- and inter-laboratory reproducibility with a lower confidence bound not less than 87% while maintaining a kappa value higher than or equal to 0.5. Based on meta-analysis, a list was established of high-risk HPV (hrHPV) assays that fulfill the cross-sectional performance criteria for cervical cancer screening [3]. This list is continuously updated as soon as data on new HPV assays b
Data Loading...
